Catheter assembly with side wall exit lumen and method therefor

ABSTRACT

A catheter assembly includes a catheter body that extends from a distal end to a proximal end. The catheter body includes a delivery lumen, and an actuator lumen, where the actuator lumen extends from a position near or at the distal end to an intermediate portion that does not extend through the proximal end of the catheter body. The catheter body optionally includes an accessory lumen that extends from at or near the distal end and terminates at an intermediate portion that does not extend through the proximal end surface of the catheter body, for example, on a side wall.

TECHNICAL FIELD

The present invention relates generally to a deflectable catheterassembly. More particularly, it pertains to a pull wire assembly for adeflectable catheter assembly.

BACKGROUND

Increase in the use of stents, leads, and ablation techniques in branchvessels has provided an increased demand on the placement techniques forthese devices. For some procedures, it is necessary to initiallyposition a guidewire into a desired part of the lumen of a desiredvessel or duct, such as a blood vessel. After the guidewire ispositioned within the desired location, a catheter or other tubulardevice may be positioned over the guidewire and used to convey othermedical instruments into the desired blood vessel or duct.

Alternatively, a guiding catheter is used to negotiate the vasculatureof a patient. One example of a guiding catheter is described in U.S.Pat. No. 4,898,577 to Badger et al. The Badger guiding catheter includesa single elongate shaft that has a deflectable distal portioncontrollable by a pull wire. Once the distal portion is at the requireddeflection or location within the patient, the guidewire or medicalinstrument is fed through a delivery lumen of the catheter.

The deflectable catheter is controlled at a proximal end of the catheterby a control handle that operates a pull wire to deflect the catheter,for example, as shown in U.S. Pat. No. 6,171,277. In many conventionalcatheters, the pull wire is disposed within a pull wire lumen, where thepull wire lumen extends from the distal portion of the shaft through anopening at the proximal end surface of the shaft. The pull wire openingat the proximal end surface is directly adjacent to a delivery lumenthat extends from the distal end through the proximal end surface, whichhas several drawbacks. For instance, blood which enters the deliverylumen at the distal end can travel to the proximal end of the shaft andenter the pull wire lumen, potentially resulting in contaminationissues. Another potential drawback is when the blood entering the pullwire lumen clots within the pull wire lumen or around the pull wire, theoperation of the pull wire is impeded, rendering it difficult tomanipulate the distal end of the shaft. Another potential drawback withthis pull wire lumen and delivery lumen is the risk of embolism.

Accordingly, what is needed is a deflectable catheter that overcomes theshortcomings of previous deflectable catheters. What is further neededis a deflectable catheter that allows for more accurate positioning ofthe distal end of the deflectable catheter.

SUMMARY

A deflectable catheter assembly includes a catheter body extending froma deflectable distal end to a proximal end and having an intermediateportion therebetween. The catheter body includes an actuator lumen and adelivery lumen, where the delivery lumen extends from the deflectabledistal end through the proximal end. The actuator lumen extends from aposition near the deflectable distal end to the intermediate portion,but not through the proximal end, and forming an exit lumen in a sidewall of the catheter body.

Several options for the deflectable catheter assembly are as follows.For instance, in one option, the assembly further includes a pull wiredisposed within the actuator lumen, where the pull wire is coupled withthe catheter body near the deflectable distal end, and optionally exitsthrough the exit lumen. In yet another option, the assembly furtherincludes a liner disposed within the actuator lumen and/or the deliverylumen. A further option includes coupling or embedding a stiffeningmember with the liner. Still further, in another option, the assemblyfurther includes a means for deflecting the deflectable distal end. Inyet another option, a means for sealing the actuator lumen is provided.

In another embodiment, a method includes forming a delivery lumen withina deflectable catheter assembly having a catheter body extending from aproximal end to a distal end. The method further includes forming acontinuous actuator lumen along only a portion of the catheter body, andnot forming a continuous actuator lumen through the distal end of thecatheter body. The method further includes disposing a pull wire withinthe actuator lumen, and removing a portion of the pull wire from theactuator lumen through an exit lumen in a sidewall of the catheter body,the exit lumen continuous with the actuator lumen.

Several options for the method are as follows. For instance, in oneoption, the method further includes disposing a medical instrumentthrough the delivery lumen and through the distal end of the catheterbody. In yet another option, the method further includes placing a linerwithin the delivery lumen and/or the actuator lumen.

In another embodiment, a catheter assembly has a catheter body extendingfrom a proximal end to a distal end and having a proximal tip and adistal tip. The catheter body further includes a side wall extendingbetween the proximal end and the distal end, a delivery lumen, and anaccessory lumen. The delivery lumen is sized to receive instrumentstherethrough, and the delivery lumen extends from proximal tip throughthe distal tip. The accessory lumen extends from the distal tip andterminates in the side wall of the catheter body, where the accessorylumen does not continuously extend from the distal tip to the proximaltip.

Several options for the catheter assembly are as follows. For instance,in one option, the catheter assembly further includes an actuator lumenextending from a location near the distal end and terminating in theside wall, where the actuator lumen does not extend through the proximaltip. In another option, the catheter is slittable without damage to aninstrument disposed within the delivery lumen. In yet another option,the catheter assembly further includes a liner disposed within theaccessory lumen. The catheter assembly further includes, in anotheroption, an instrument disposed within the accessory lumen, such as asensor, or a fiber optic assembly.

The deflectable catheter assembly provides a catheter assembly that iseasy to use and manipulate, and does not interfere with the physician'sability to manipulate the deflectable catheter assembly. Furthermore,the catheter assembly design assists in preventing air leakage from theactuator lumen. The catheter assembly further prevents co-mingling offluids from the delivery lumen to the actuator lumen, and preventsfluids from entering the actuator lumen and/or the accessory lumen.

These and other embodiments, aspects, advantages, and features of thepresent invention will be set forth in part in the description whichfollows, and in part will become apparent to those skilled in the art byreference to the following description of the invention and referenceddrawings or by practice of the invention. The aspects, advantages, andfeatures of the invention are realized and attained by means of theinstrumentalities, procedures, and combinations particularly pointed outin the appended claims and their equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view illustrating a deflectable catheterassembly constructed in accordance with one embodiment.

FIG. 1B is a perspective view illustrating a deflectable catheterassembly constructed in accordance with one embodiment.

FIG. 2 is a perspective view illustrating a deflectable catheter bodyconstructed in accordance with one embodiment.

FIG. 3 is a perspective view illustrating a distal portion of thedeflectable catheter body constructed in accordance with one embodiment.

FIG. 4 is an end view of the distal end of the deflectable catheterassembly constructed in accordance with one embodiment.

FIG. 5 is an end view of the proximal end of the deflectable catheterassembly constructed in accordance with one embodiment.

FIG. 6 is a cross-sectional view illustrating a portion of thedeflectable catheter assembly constructed in accordance with oneembodiment.

FIG. 7 is a side view illustrating a portion of a catheter bodyconstructed in accordance with another embodiment.

FIG. 8 is a cross-sectional view illustrating a distal end portion of acatheter body constructed in accordance with another embodiment.

FIG. 9 is a perspective view illustrating a proximal end portion of acatheter body constructed in accordance with one embodiment.

DESCRIPTION OF THE EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and that structuralchanges may be made without departing from the scope of the presentinvention. Therefore, the following detailed description is not to betaken in a limiting sense, and the scope of the subject matter of thisapplication is defined by the appended claims and their equivalents.

FIGS. 1A and 1B illustrate a deflectable catheter assembly 100, whereFIG. 1A illustrates the deflectable catheter assembly 100 in anarticulated position, and FIG. 1B illustrates the deflectable catheterassembly 100 in an unarticulated position. The deflectable catheterassembly 100 includes a deflectable catheter body 110 and a handleassembly 150 that houses steering mechanisms for deflection of thecatheter body 110. The handle assembly 150 allows for the deflection ofa distal end of the catheter body 110. One example of the handleassembly 150 is described in co-pending application Ser. No. 10/179,633,assigned to Enpath Medical, Inc., and is entitled “Articulating HandleFor a Deflectable Catheter,” which is incorporated herein by reference.In one option, the pull wire 120 is connected to an actuator that isslid or rotated to apply tension to the pull wire 120. As tension isapplied to the pull wire 120, the pull wire anchor at the distal end ofthe catheter body 110 is pulled causing the distal portion of thecatheter body 110 to curve in a predetermined direction or directions.

With reference to FIG. 2, the catheter body 110 comprises an elongatetubular construction that is flexible yet substantially non-compressiblealong its length. The deflectable catheter body 110 extends from aproximal end 102 to a distal end 104, where the distal end 104 isdisposed within a patient. At the proximal end 102 is a proximal tip103, and at the distal end 104 is a distal tip 105. At the proximal end102, the physician controls the deflection of the deflectable catheterbody 110 with the handle assembly 150 (FIGS. 1A and 1B) and a pull wire120 (FIG. 3), as further described below. The distal end 104 isdeflected to traverse various branch vessels with the catheter assembly100 (FIG. 1).

FIG. 3 illustrates a partial cut-away view of FIG. 2, including thedistal end 104 of the catheter body 110. The catheter body 110 includesa pull wire anchor 121 that is secured to the catheter body 110. Thepull wire 120 is secured to the pull wire anchor 121, for example, asdescribed in co-pending U.S. Provisional Patent Application entitled“Pull Wire Anchor For A Removable Medical Device And A Method Therefor,”assigned to Enpath Medical, Inc., and having Ser. No. 60/409,494, whichis incorporated herein by reference. It should be noted that the pullwire can be secured to the distal end 104 of the catheter body 110 inother manners. The pull wire anchor 121, in one option, comprises amarker band 119 that is viewable, for example, under fluoroscopy. In oneoption, the catheter body 110 includes a stiffening member embeddedtherein, such as a braided stainless steel member 111. The stiffeningmember facilitates rotation of the distal end 104 from the proximal end102, and also assists in preventing the catheter body 110 fromcollapsing.

FIG. 4 illustrates an end-view of the catheter body 110 at its, distalend 104 (FIG. 2). The catheter body 110 is further defined by an outershaft surface 112. Disposed within the deflectable catheter body 110includes at least one delivery lumen 130 that extends from the proximalend through the catheter body distal end 104. In one option, thedelivery lumen 130 is lined with liner material 132, for example, PTFE.The lining of the delivery lumen 130 allows for instruments to be moreeasily inserted therethrough.

The delivery lumen 130 provides a passage from the controlling end tothe distal end, such that a physician can insert a device or fluid in atthe proximal end and it will travel through the catheter body 110 to thedistal end 104 (FIG. 2), where it will exit the catheter body 110. Thedeflectable nature, of the body 110, in conjunction with the steeringassembly, allows for a physician to direct the application of a deviceand/or medicine or fluid to a particular location within a patient. Thedelivery lumen 130 is configured to receive a variety of medical devices134 therethrough. For example, suitable devices include, but are notlimited to, leads, stents, dilators, guidewires, EP mapping catheters,ablation devices, etc. Alternatively, fluids and/or medicine can bedistributed and targeted to a certain location using the deflectablecatheter assembly 100 (FIG. 1A).

As mentioned above, the deflectable catheter assembly 100 (FIG. 1A)further includes a pull wire 120 associated therewith, where the pullwire 120 is received within an actuator lumen 122. The actuator lumen122 is disposed within the catheter body 110, and the pull wire 120 ismovably disposed within the actuator lumen 122. The actuator lumen 122extends from a location near or at the distal end 104 (see FIG. 3) to anintermediate location that does not extend through the proximal end 102(see FIG. 2). For example, the actuator lumen 122 terminates at alocation in a side wall 124 of the catheter body 110. FIG. 5 illustratesan end view of the catheter body 110 at the proximal end. The lumen 122does not extend to the proximal end nor to the proximal tip of thecatheter body 110. Therefore, there is no cross-contamination of fluidsor gasses from the delivery lumen 130 to the actuator lumen 122, or viceversa.

In one option, the actuator lumen 122 further includes an actuator lumenliner 126 therein. The actuator lumen liner 126 forms a lumen therein,where the lumen receives the pull wire 120 therein. The actuator lumenliner 126 is formed of PTFE in one option. Other suitable materials forthe actuator lumen liner 126 include, but are not limited to, FEP orpolyether-block-amide.

In yet another option, the actuator lumen liner 126 further includes astiffening member such as braided material. The braided material assistsin preventing the actuator lumen liner 126 from collapsing when theactuator lumen liner 126 is pulled out a side lumen, as furtherdescribed below.

As shown in FIG. 3, the actuator lumen liner 126 extends from a location131 near the distal end 104. In one option, the distal end 127 of theactuator lumen liner 126 is spaced away from the anchor 121 a distance“d”. This allows for improved manufacturability of the catheter body 110assembly. For instance, if the pull wire is not perfectly aligned withthe pull wire anchor 121, this can result in irregularities in the outerdiameter if the actuator lumen liner 126 extends up to the anchor 121.

The actuator lumen liner 126 extends along the catheter body 110 to alocation near the proximal end 102, as shown in FIG. 6. The actuatorliner 126 exits through a side wall 124 of the catheter body 110 at 129.For example, in one option, the actuator lumen liner 126 is pulledthrough the side wall 124 of the catheter body 110 through an exit lumen128 of the catheter body 110. The actuator lumen liner 126 does notcontinue within the catheter body 110 through the proximal end 102, anddoes not continue through the proximal tip of the catheter body 110. Theactuator lumen liner 126 assists in sealing the proximal end of thecatheter body 110, which prevents fluids exiting or co-mingling at theproximal end of the catheter body 110. In one option, a seal is formedaround the actuator lumen liner 126 with material 188 reflowed around aportion of the actuator lumen liner 126.

FIG. 7 illustrates another option for the catheter body 110′. Thecatheter body 110′ includes at least a first segment 150 and a secondsegment 152. In one option, the first segment 150 has a differentdurometer than the second segment 152. The first segment 150 is formedseparate from the second segment, and the first segment includes adelivery lumen and an actuator lumen therein, as discussed above. Thesecond segment 152 includes a delivery lumen, as discussed above.However, there are no lumens in the second segment 152 which are coupledwith the actuator lumen. In one embodiment, the second segment 152 formsthe proximal end of the catheter body 110′, and the first segment 150forms the intermediate portion of the catheter body 110′. In anotheroption, a third segment having a different structure forms the distalend of the catheter body 110′. It should be noted that more segments arefurther options.

In yet another option, the catheter body 110′ includes a notch 160 inthe second segment 152 at a location 154 adjacent the first segment 150.The notch 160 allows for the actuator lumen liner (discussed above) totransition and exit more easily from an interior portion of the firstsegment 150, where the lumen and/or the liner do not extend through theproximal end surface of the catheter body 110′. The stress on theactuator lumen liner is reduced, and a smoother transition occurs.

To form the catheter assembly, in one example, the delivery lumen lineris placed over a mandrel, and the actuator lumen liner is threaded overthe pull wire and placed over the delivery lumen liner. The pull wireanchor is placed over the delivery lumen liner and coupled with the pullwire. Stiffening material is optionally placed over the delivery lumenliner and the actuator lumen liner. Outer tubing is placed over thedelivery lumen liner, which will form the outer surface of the catheterbody. The items are held together, for example, by placing shrink tubingthereover and heating the shrink tubing. The items are reflowedtogether, a process which blends the material of the outer tubing,actuator lumen liner, and the delivery lumen liner. The shrink tubing isremoved from the assembly.

To form the proximal end, an outer jacket is slid over a proximal end ofthe delivery lumen liner, but not over the actuator lumen liner. Theouter jacket abuts the first outer jacket discussed above, and the itemsare secured together, for example, by heat shrink tubing. These elementsare reflowed together, and the shrink tubing is removed. The deflectablecatheter body assembly is coupled with a handle assembly with a steeringmechanism to form the deflectable catheter assembly.

In another embodiment, as shown in FIGS. 8 and 9, the catheter assembly100″ further includes an accessory lumen 190. It should be noted thatthe embodiments shown in FIGS. 8 and 9 can be incorporated with any ofthe above-discussed embodiments. The accessory lumen 190 is disposedadjacent to the delivery lumen 130, and in one option, the accessorylumen 190 has a substantially smaller diameter than the delivery lumen130. The delivery lumen 130, as discussed above, extends from a locationin the distal end surface 170 through the proximal tip 172. Theaccessory lumen 190 extends from a location, in one option, in thedistal tip 170 to a location 180 not in the proximal tip 172, forexample, terminating at a location on the side wall 124 of the catheterbody 110.

In another option, a liner 192 is disposed within the accessory lumen190. The liner 192 includes, but is not limited to, the materialsdiscussed above for the actuator lumen. In yet another option, astiffening member, such as a braided member, is disposed adjacent to, orsurrounding the accessory lumen 190, which assists in preventing theaccessory lumen 190 from collapsing. The accessory lumen 190 is sized toreceive therein accessories 194. For instance, a fiber optic instrumentis disposed within the accessory lumen 190. The fiber optic instrumentcan be used to assist in directing the distal end of the catheter body110 within the patient. This allows for a reduction or elimination ofradiation exposure, for example, radiation exposure that occurs duringfluoroscopic procedures. Other types of instruments can be disposed inthe accessory lumen 190 as well, for example, an instrument 194 canincludes one or more sensors 196 thereon.

To form the catheter assembly 100″, the delivery lumen liner is placedover a mandrel, and the optional actuator lumen liner is optionallythreaded over the pull wire and placed over the delivery lumen liner.The pull wire anchor is placed over the delivery lumen liner and coupledwith the pull wire. An instrument, such as an instrument with a sensoror an instrument such as a fiber optic instrument is placed over thedelivery lumen liner. Stiffening material is optionally placed over thedelivery lumen liner, the actuator lumen liner, and the instrument.Outer tubing is placed over the delivery lumen liner, the optionalactuator lumen liner, and the instrument, which will form the outersurface of the catheter body. The items are held together, for example,by placing shrink tubing thereover and heating the shrink tubing. Theitems are reflowed together, a process which blends the material of theouter tubing, actuator lumen liner, the instrument, and the deliverylumen liner. The shrink tubing is removed from the assembly.

To form the proximal end of the catheter assembly, an outer jacket isslid over a proximal end of the delivery lumen liner, but not over theactuator lumen liner nor the instrument. The outer jacket abuts thefirst outer jacket discussed above, and the items are secured together,for example, by heat shrink tubing. These elements are reflowedtogether, and the shrink tubing is removed. The deflectable catheterbody assembly is coupled with a handle assembly with a steeringmechanism to form the deflectable catheter assembly.

Advantageously, the deflectable catheter assembly provides a catheterassembly that is easy to use and manipulate, and does not interfere withthe physician's ability to manipulate the deflectable catheter assembly.Furthermore, the catheter assembly design assists in preventing leakagefrom the actuator lumen and/or the accessory lumen. The catheterassembly further prevents co-mingling of fluids from the delivery lumento the actuator lumen and/or the accessory lumen, and prevents fluidsfrom entering the actuator lumen and/or the accessory lumen. Theaccessory lumen and/or the accessory lumen provide for more flexibilityduring implant procedures, and provides for more options with thecatheter assembly.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. It should be noted that embodiments discussed indifferent portions of the description or referred to in differentdrawings can be combined to form additional embodiments of the presentinvention. Furthermore, although a deflectable catheter assembly hasbeen discussed throughout, it should be understood that the actuatorlumen and the accessory lumen, and the various combinations discussedand/or shown in the application can be incorporated within other typesof catheter assemblies, including, but not limited to, radiopaquecatheter assemblies, non-deflectable catheter assemblies or slittablecatheter assemblies, or slittable catheter assemblies, or catheterassemblies removable in any fashion from instruments disposed therein.The scope of the invention should, therefore, be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

1. A deflectable catheter assembly comprising: a catheter body extending from a deflectable distal end to a proximal end and having an intermediate portion therebetween; the catheter body including an actuator lumen and a delivery lumen; the delivery lumen extending from the deflectable distal end through the proximal end; the actuator lumen extending from a position near the deflectable distal end to the intermediate portion and not through the proximal end; the actuator lumen exiting the catheter body forming an exit lumen on a side wall of the catheter body; and a liner, wherein at least a portion of the liner extends toward the proximal end from the exit lumen and is outside of the catheter body, and the liner is sealed around the exit lumen, and a lumen extends through the liner and through at least a portion of the actuator lumen.
 2. The deflectable catheter assembly as recited in claim 1, further comprising a pull wire disposed within the actuator lumen, the pull wire coupled with the catheter body near the deflectable distal end.
 3. The deflectable catheter assembly as recited in claim 2, wherein the pull wire exits through the exit lumen.
 4. The deflectable catheter assembly as recited in claim 1, further comprising a liner disposed within the actuator lumen.
 5. The deflectable catheter assembly as recited in claim 1, further comprising a means for deflecting the deflectable distal end.
 6. The deflectable catheter assembly as recited in claim 1, further comprising a delivery lumen liner disposed within the delivery lumen.
 7. The deflectable catheter assembly as recited in claim 1, wherein the catheter body is slittable without damage to an instrument disposed therein.
 8. The deflectable catheter assembly as recited in claim 1, further comprising a stiffening member coupled with the liner.
 9. The deflectable catheter assembly as recited in claim 1, wherein the liner is formed of PTFE.
 10. The deflectable catheter assembly as recited in claim 1, wherein a proximal tip of the catheter body does not have a lumen coupled with the actuator lumen.
 11. The deflectable catheter assembly as recited in claim 1, further comprising a medical instrument disposed through the delivery lumen.
 12. The deflectable catheter assembly as recited in claim 1, wherein the liner is sealed around the exit lumen with reflowed material disposed around the liner.
 13. The deflectable catheter assembly as recited in claim 1, wherein the catheter body has an accessory lumen therein, the accessory lumen extending from a position near the deflectable distal end and terminating in the intermediate portion, and the accessory lumen does not continuously extend from the deflectable distal end to the proximal end.
 14. The deflectable catheter assembly as recited in claim 1, wherein the catheter body has an accessory lumen therein, the accessory lumen extending from a position near the deflectable distal end and terminating in the intermediate portion, and the accessory lumen does not continuously extend from the deflectable distal end to the proximal end. 